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Medical Devices Sector
قطاع الأجهزة الطبية
NCMDR
National Center for Medical Devices Reporting
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
NCMDR Recall
Reference Number: mdprc 033 01 16 000
Date submitted: 1/10/2016
Manufacturer:GE Healthcare
Device Type:GE PRN 50-M+ Digital Writers
Description:Printer/Graphic Recorders
Medical Device Identifier:GE Part No. 2062759-001; Manufacturer Part No. 600-23310-01; Serial Nos.: 1801405 through 1918761
Reason of Field Safety Corrective Action:Outer Enclosure Material May Not Meet Intended Flammability and Fluid Ingress Ratings
Remedy Action:Identify any affected product in your inventory. If you have affected product, verify that you have received the November 18, 2015, Medical Device Correction Notice letter and Confirmation form from GSI. GSI states that users should follow all usage, cleaning, and maintenance instructions provided in the technical manual for the affected product. Complete the Confirmation form, and return it to GSI using the instructions on the form. GSI will provide your facility with a product correction at no charge. Notify all relevant personnel at your facility of the information in the letter.
Athorized Representative/Importer/Distributor:GE Healthcare
Report Source:NCMDR
Source Ref. Number:6D73DF615A27A
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: GE Healthcare.pdf